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Alkermes Plc (ALKS.OQ)

ALKS.OQ on NASDAQ Stock Exchange Global Select Market

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Latest Key Developments (Source: Significant Developments)

Alkermes, certain subsidiaries enter into amendment to amended, restated credit agreement
Thursday, 13 Oct 2016 04:17pm EDT 

Alkermes Plc : Alkermes - On Oct. 12, co, certain other subsidiaries of company entered into an amendment to amended and restated credit agreement - SEC filing . Alkermes - Amendment amends credit agreement to extend maturity date of the about $286 million outstanding term loan by two years to September 25, 2021 Source: (http://bit.ly/2e5hN5b) Further company coverage: [ALKS.O] ((bangalore.newsroom@thomsonreuters.com;)).  Full Article

Alkermes submits supplemental new drug application to FDA
Monday, 8 Aug 2016 07:00am EDT 

Alkermes Plc : Alkermes submits supplemental new drug application to FDA for two month dosing option of Aristada® for treatment of schizophrenia . Notice of allowance issued for Aristada patent application, extending expected protection into 2035 .Expects patent to issue within next few months and expire no earlier than march 2035.  Full Article

Alkermes says U.S. District Court issued unambiguous opinion in favor of co, U.S. FDA - SEC filing
Friday, 29 Jul 2016 12:55pm EDT 

Alkermes Plc: On July 28 U.S. District Court for District of Columbia issued unambiguous opinion in favor of co and U.S. FDA - SEC filing . U.S. District Court unambiguous opinion affirming in all respects FDA's decision to approve Aristada for treatment of schizophrenia .U.S. District Court unambiguous opinion also "denying action filed by Otsuka for declaratory and injunctive relief".  Full Article

Alkermes PLC gives FY 2016 guidance
Thursday, 25 Feb 2016 07:01am EST 

Alkermes PLC:Expects FY 2016 total revenues to range from $700 million to $750 million.Expects FY 2016 GAAP net loss to be in range of $225 million to $255 million, or a basic and diluted loss per share of $1.48 to $1.68.Expects FY 2016 non-GAAP net loss to be in the range of $25 million to $55 million, and non-GAAP basic and diluted loss per share to be between $0.16 and $0.36.  Full Article

Alkermes PLC announces positive topline results from clinical study of Two-month dosing option of ARISTADA for treatment of Schizophrenia
Thursday, 25 Feb 2016 07:00am EST 

Alkermes PLC:Announces positive topline results from clinical study of Two-month dosing option of ARISTADA for treatment of Schizophrenia.Results showed 1064 mg dose of aristada achieved therapeutically relevant plasma concentrations of aripiprazole with pk profile.Says most common adverse events for the two-month dosing interval were injection site pain and dyskinesia.Plans to submit supplemental new drug application to the U.S. food and drug administration (FDA) in the second half of 2016.Says potential new offering would expand range of aristada doses to three interval options.  Full Article

Alkermes PLC announces initiation of phase 1 clinical study of New CNS Drug Candidate ALKS 7119
Monday, 25 Jan 2016 07:00am EST 

Alkermes PLC:Announced the initiation of a phase 1 clinical study of ALKS 7119.Double-blind, placebo-controlled study will evaluate the safety and tolerability of single ascending doses of ALKS 7119 in approximately 60 healthy subjects.  Full Article

Alkermes PLC depression drug fails in two late-stage studies - Reuters
Thursday, 21 Jan 2016 07:13am EST 

Alkermes PLC:Alkermes Plc ALKS.O said its drug for major depressive disorder did not meet the main goal of improving depression symptoms in two late-stage studies - RTRS.However, a clear trend of efficacy was observed with the 2 mg dose of the drug, ALKS 5461, the company said. - RTRS.The studies were evaluated using the Montgomery–Åsberg Depression Rating Scale (MADRS), which is commonly used to measure the severity of depressive episodes in patients. - RTRS.  Full Article

Alkermes PLC announces topline results of FORWARD-3 and FORWARD-4, Two Phase 3 Studies of ALKS 5461 in Major Depressive Disorder
Thursday, 21 Jan 2016 07:00am EST 

Alkermes PLC:Announced preliminary topline results from FORWARD-3 and FORWARD-4, the first two of three phase 3 efficacy studies to read out from the comprehensive FORWARD pivotal program for ALKS 5461.Neither of the two studies met the prespecified primary efficacy endpoint, which compared ALKS 5461 to placebo on the change from baseline on the Montgomery-Åsberg Depression Rating Scale.  Full Article

Alkermes PLC announces positive clinical trial results and streamlined registration pathway for ALKS 8700 for treatment of multiple sclerosis
Thursday, 29 Oct 2015 07:00am EDT 

Alkermes PLC:Announces positive clinical trial results and streamlined registration pathway for ALKS 8700 for treatment of multiple sclerosis.Says on track to initiate registration program for novel twice-daily oral candidate by end of 2015 and file nda in 2018.  Full Article

Alkermes PLC Says FDA Approves ARISTADA for Treatment of Schizophrenia
Monday, 5 Oct 2015 06:23pm EDT 

Alkermes Plc :FDA approves Aristada for treatment of Schizophrenia.Says Alkermes is preparing to launch ARISTADA immediately.  Full Article

More From Around the Web

BRIEF-Alkermes CEO Richard Pops' 2016 total compensation was $9.6 mln vs $12.4 mln in 2015

* CEO Richard Pops' 2016 total compensation was $9.6 million versus $12.4 million in 2015 - sec filing Source text (http://bit.ly/2p9SZ48) Further company coverage: